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RSS FeedPosted by Michael Wonder on 19 Jun 2024
European Commission grants Sobi marketing authorisation for Altuvoct for treatment of haemophilia A
19 June 2024 - Sobi today announced the European Commission has granted marketing authorisation for Altuvoct's (efanesoctocog alfa), for the ...
Posted by Michael Wonder on 30 Jan 2024
Takeda’s Hyqvia approved by European Commission as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
30 January 2024 - At home or in office administration provides CIDP patients with a personalised treatment experience. ...
Posted by Michael Wonder on 17 Dec 2023
Takeda receives positive CHMP opinion for Hyqvia as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy
15 December 2023 - Positive opinion based on Phase 3 ADVANCE-CIDP 1 study, which met its primary endpoint demonstrating a statistically ...
Posted by Michael Wonder on 20 May 2023
EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
19 May 2023 - Sobi today announced that the EMA has accepted and validated a marketing authorisation application for efanesoctocog alfa, ...
Posted by Michael Wonder on 26 Jul 2022
LFB announces the approval of Cevenfacta (eptacog beta) in the European Union
25 July 2022 - The first new bypassing agent approved in the European Union for the treatment and control of bleeding ...
Posted by Michael Wonder on 01 Mar 2021
LFB announces that the EMA has accepted for filing the marketing authorisation application for eptacog beta (activated), a recombinant coagulation factor VIIa
1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...
Posted by Michael Wonder on 31 Oct 2020
Extra transparency measures for COVID-19 vaccines and therapeutics
30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...
Posted by Michael Wonder on 16 Sep 2020
EMA approves label update for Hyqvia (human normal immunoglobulin 10% and recombinant human hyaluronidase), expanding its use to a broader group of patients with secondary immunodeficiencies
15 September 2020 - Takeda today announced that the EMA has approved a label update for Hyqvia (human normal immunoglobulin 10% ...
Posted by Michael Wonder on 03 May 2020
Pharming receives European Commission approval for treatment of acute hereditary angioedema attacks in children with Ruconest
30 April 2020 - European Commission decision was received six weeks earlier than expected. ...
Posted by Michael Wonder on 06 Nov 2019
Octapharma’s fibryga receives European label extension to treat acquired fibrinogen deficiency (AFD)
5 November 2019 - Octapharma announced today that the human fibrinogen concentrate fibryga has received approval for use in treatment of ...
Posted by Michael Wonder on 21 Jun 2019
Esperoct (turoctocog alfa pegol, N8-GP) approved in the EU
20 June 2019 - Novo Nordisk today announced that the European Commission has granted marketing authorisation for Esperoct for the treatment ...
Posted by Michael Wonder on 30 Nov 2018
Data from patient registries to replace clinical trials in previously untreated haemophilia patients
30 November 2018 - EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications ...
Posted by Michael Wonder on 28 Nov 2018
Bayer receives EU approval for its haemophilia A treatment Jivi
27 November 2018 - The safety and efficacy profile of Jivi has been demonstrated in more than five years of clinical ...
Posted by Michael Wonder on 24 Sep 2018
Bayer receives positive CHMP opinion for its haemophilia A treatment BAY94-9027
21 September 2018 - The safety and efficacy profile of BAY94-9027 has been demonstrated in more than five years of clinical ...
Posted by Michael Wonder on 23 Sep 2018
Highlights from the 17-20 September CHMP meeting
21 September 2018 - CHMP elects new chair and recommends thirteen medicines for approval. ...